Current through Register No. 40, October 3, 2024
(a) Upon a
determination that an application meets the requirements of the applicable
sections of He-P 4000, He-P 4030, and RSA 125-F, DHHS/RHS shall issue a
specific license authorizing the proposed activity.
(b) DHHS/RHS shall incorporate into any
license issued pursuant to this part and He-P 4031 through 4036, and He-P 4039,
at the time of issuance or thereafter, by appropriate rule or order, such
additional requirements and conditions with respect to the licensee's receipt,
possession, use, and transfer of byproduct material as it deems appropriate or
necessary in order to:
(1) Protect the public
health and minimize danger to life or property;
(2) Require such reports and the keeping of
such records, and to provide for such inspections of activities under the
license as may be appropriate or necessary; and
(3) Prevent loss or theft of material subject
to this part.
(c)
Specific licenses shall be issued to named persons upon applications filed
pursuant to He-P 4030.
(d) Each
license issued pursuant to this part and parts He-P 4031 through 4036, and He-P
4039, shall be subject to all of the provisions of RSA 125-F and to the
administrative rules in chapter He-P 4000. Said licenses shall also be subject
to any temporary orders issued pursuant to the governor's state of emergency by
the commissioner when necessary to protect the health and safety of employees,
the general public, or the security of certain types of radioactive materials
during the declared state of emergency.
(e) Neither the license nor any right under
the license issued or granted pursuant this part and parts He-P 4031 through
4036, and He-P 4039, shall be assigned or otherwise transferred in violation of
the provision of RSA 125-F.
(f)
Each person licensed by DHHS/RHS pursuant to this part shall confine his or her
use and possession of the material licensed to conditions specified on the
license, such as:
(1) Standard licensing
conditions as set forth in these rules, or
(2) Conditions formulated specifically for an
individual license.
(g)
Each licensee shall notify DHHS/RHS in writing when the licensee decides to
permanently discontinue all activities involving materials authorized under the
license.
(h) Each general licensee
that is required to register by He-P 4031, and each specific licensee, shall
notify DHHS/RHS in writing immediately following the filing of a voluntary or
involuntary petition for bankruptcy under any Chapter of Title 11 of the United
States Code by or against:
(1) The
licensee;
(2) An entity, as that
term is defined in 11 U.S.C.
101(15), controlling the
licensee or listing the license or licensee as property of the estate;
or
(3) An affiliate, as that term
is defined in 11 U.S.C.
101(2), of the
licensee.
(i) The
notification specified in
He-P
4030.10(h) shall indicate the
bankruptcy court in which the petition for bankruptcy was filed and the date of
the filing of the petition.
(j)
Each licensee shall notify DHHS/RHS of radiological incidents and events, as
follows:
(1) As soon as possible but not
later than 4 hours after the discovery of an event that prevents immediate
protective actions necessary to avoid exposures to radiation or radioactive
materials that could exceed the limits specified in He-P 4020, or releases of
licensed material that could exceed the limits specified in He-P 4020;
and
(2) Within 24 hours after the
discovery of any of the following events involving licensed material:
a. An unplanned contamination event that:
1. Requires access to the contaminated area,
by workers or the public, to be restricted for more than 24 hours by imposing
additional radiological controls or by prohibiting entry into the
area;
2. Involves a quantity of
radioactive material greater than 5 times the lowest annual limit of intake
specified in He-P 4090 or the equivalent 10 CFR 20 Appendix B for the material;
and
3. Requires access to the area
to be restricted for a reason other than to allow isotopes with a half-life of
less than 24 hours to decay prior to decontamination;
b. An event in which equipment is disabled or
fails to function as designed when:
1. The
equipment is required by the rules or license condition to prevent releases
exceeding regulatory limits, to prevent exposures to radiation and radioactive
materials exceeding the limits specified by He-P 4020, or to mitigate the
consequences of an accident;
2. The
equipment is required to be available and operable when it is disabled or fails
to function; and
3. No redundant
equipment is available and operable to perform the required safety
function;
c. An event
that requires unplanned medical treatment at a medical facility of an
individual with spreadable radioactive contamination on the individual's
clothing or body; and
d. An
unplanned fire or explosion damaging any licensed material or any device,
container, or equipment containing licensed material when:
1. The quantity of radioactive material
involved is greater than 5 times the lowest annual limit on intake specified in
for the material; and
2. The damage
affects the integrity of the licensed material or its container.
(k) Licensees
shall make reports to DHHS/RHS required by
He-P
4030.10(j)(1) and (2) above, by
telephone via the New Hampshire state police communications center at (603)
271-3636.
(l) To the extent that
the information is available at the time of notification, the information
provided in the telephonic report pursuant to (k) above shall include:
(1) The caller's name and call back telephone
number;
(2) A description of the
event, including date and time;
(3)
The exact location of the event;
(4) The isotopes, quantities, and chemical
and physical form of the licensed material involved; and
(5) Any personnel radiation exposure data
available.
(m) Each
licensee who makes a report required by
He-P
4030.10(j)(1) or (2) shall submit to
DHHS/RHS a written follow-up report within 30 days of the initial report, which
includes the following information:
(1) A
description of the event, including the probable cause and the manufacturer and
model number (if applicable) of any equipment that failed or
malfunctioned;
(2) The exact
location of the event;
(3) The
isotopes, quantities, and chemical and physical form of the licensed material
involved;
(4) Date and time of the
event;
(5) Corrective actions taken
or planned and the results of any evaluations or assessments; and
(6) The extent of exposure of individuals to
radiation or to radioactive materials without identification of individuals by
name.
(n) Relative to
records, each person who receives byproduct material pursuant to a license
issued pursuant He-P 4030 through He-P 4039 shall:
(1) Keep records showing the receipt,
transfer, and disposal of the source or byproduct material, as follows:
a. The licensee shall retain each record of
receipt of source or byproduct material as long as the material is possessed
and for 3 years following transfer or disposal of the source or byproduct
material;
b. The licensee who
transferred the radioactive material shall retain each record of transfer of
source or byproduct material until DHHS/RHS terminates each license that
authorizes the activity that is subject to recordkeeping requirement;
c. The licensee who disposed of the source or
byproduct material shall retain each record of disposal of radioactive material
until the license that authorizes disposal of the material is terminated;
and
d. If source or byproduct
material is combined or mixed with other licensed material and subsequently
treated in a manner that makes direct correlation of a receipt record with
transfer, export, or disposition record impossible, the licensee shall use
evaluative techniques, such as, first-in-first-out, to make the records that
are required by He-P 4030 account for 100 percent of the material
received;
(2) Retain each
record that is required by this chapter or by license condition for the period
specified by the applicable rule or license condition, except that if a
retention period is not otherwise specified by rule or license condition, the
record shall be retained until the license authorizing the activity that is
subject to the recordkeeping requirement is terminated;
(3) Retain records required to be maintained
pursuant to this chapter in the following format:
a. The original;
b. A reproduced copy, if such reproduced copy
is duly authenticated by authorized personnel;
c. Microform, if such microform is duly
authenticated by authorized personnel and is capable of producing a clear and
legible copy after storage for the period specified by the rules; or
d. Stored in electronic media with the
capability for producing legible, accurate, and complete records during the
required retention period;
(4) Ensure that all pertinent information,
including stamps, initials, and signatures, are included on all required
records, including letters, drawings, specifications;
(5) Maintain adequate safeguards against
tampering with and loss of records;
(6) Prior to termination of a license
authorizing possession of radioactive material with a half-life greater than
120 days, in an unsealed form, forward the following records to DHHS/RHS:
a. Records of disposal of licensed material
made under He-P 4023; and
b.
Records required by He-P
4021.03(c)(4);
(7) At the time of transfer of a radioactive
material license authorizing possession of radioactive material with a
half-life of greater than 120 days, in an unsealed form, transferred or
assigned in accordance with
He-P
4030.15 to a new licensee, transfer the following
records to the new licensee and the new licensee will be responsible for
maintaining these records until the license is terminated, the following:
a. Records of disposal of licensed material
made under He-P 4023; and
b.
Records required by He-P
4021.03(c)(4);
and
(8) Prior to license
termination, forward the records to DHHS/RHS as required by
He-P
4030.09(o) - (r).
(o) Relative to licensees preparing
technetium-99m radiopharmaceuticals from molybdenum- 99/technetium-99m
generators or rubidium-82 from strontium-82/rubidium-82 generators, each
licensee shall test the generator eluates for molybdenum-99 breakthrough or
strontium-82 and strontium- 85 contamination, respectively, in accordance with
He-P
4035.32(a) through (d). The licensee
shall record the results of each test and retain each record for 3 years after
the record is made. The licensee shall report the results of any test that
exceeds the permissible concentration listed in
He-P
4035.32(a) at the time of the
generator elution, in accordance with
He-P
4035.32(e).
(p) Relative to licensees authorized under
He-P
4030.07(k) to produce:
(1) PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium shall not relieve the
licensee from complying with applicable DHHS/RHS, or agreement state, or
federal requirements governing radioactive drugs; and
(2) PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium, the licensees shall
satisfy:
a. The labeling requirements in
He-P
4032.05(a)(4) for each PET
radioactive drug transport radiation shield and each syringe, vial, or other
container used to hold a PET radioactive drug intended for noncommercial
distribution to members of the licensees consortium; and
b. The requirement for using instrumentation
to measure the radioactivity of the PET radioactive drugs intended for
noncommercial distribution to members of the licensees' consortium and meet the
procedural, radioactivity measurement, instrument test, instrument check, and
instrument adjustment requirements of
He-P
4032.05(d).
(q) Relative to
pharmacies authorized under
He-P
4030.07(k) to produce PET radioactive
drugs for noncommercial transfer to medical use licensees in its consortium,
each pharmacy shall require that any individual who prepares PET radioactive
drugs shall be:
(1) An authorized nuclear
pharmacist that meets the requirements in
He-P
4032.05(b)(2);
(2) An individual under the supervision of an
authorized nuclear pharmacist as specified in
He-P
4035.11; or
(3) An individual working as an authorized
nuclear pharmacist who meets the requirements of
He-P
4032.05(b)(2).
(r) Relative to portable gauge licensees,
each licensee shall:
(1) Secure the portable
gauges such that each portable gauge license shall use a minimum of 2
independent physical controls that form tangible barriers to secure portable
gauges from unauthorized removal, whenever portable gauges are not under the
control and constant surveillance of the licensee; and
(2) Maintain utilization logs for 3 years for
each source of radiation which contains the following information:
a. A description, including the make, model,
and serial number of each sealed source and each device in which the sealed
source is located;
b. The location
and dates of use, including the dates removed and returned to storage;
and
c. The identity and signature
of the user of the device.
(s) Relative to licensee's survey
instruments, each licensee shall:
(1) Keep
sufficient calibrated and operable radiation survey instruments at each
location where sources of radiation are present to make the radiation surveys
required by He-P 4022;
(2) Have
each radiation survey instrument calibrated:
a. At energies appropriate for use and at
intervals not to exceed 12 months or after instrument servicing, except for
battery changes;
b. For linear
scale instruments, at 2 points located approximately one-third and two-thirds
of full scale on each scale. For logarithmic scale instruments, at mid-range of
each decade, and at 2 points of at least one decade. For digital instruments,
at 3 points between 0.02 and 10 millisieverts (2 and 1,000 mrem) per hour;
and
c. So that an accuracy within
plus or minus 20 percent at the calibration source can be demonstrated at each
point checked; and
(3)
Maintain records of the annual calibrations of its radiation survey instruments
and retain each record for 3 years after it is made.
(See Revision Note at part heading for He-P 4030) #6942,
eff 2-1-99; ss by #8488, eff 11-18-05; ss by #8959, eff
8-7-07
